Vaccine trials off to fast start for pandemic fluUpdated | Comment | Recommend E-mail | Save | Print |Nurse Carolyn Stefanski gives a shot to Nicholas Sarakas, 25, of St.Peters, during an H1N1 vaccination trial at the Saint Louis UniversityHospital in St. Louis, Mo. "Somebody has to do it, and I was probablygoing to get it anyway," Sarakas said.Enlarge image Enlarge By Emily Rasinski, St. Louis Post-Dispatch viaAPNurse Carolyn Stefanski gives a shot to Nicholas Sarakas, 25, of St.Peters, during an H1N1 vaccination trial at the Saint Louis UniversityHospital in St. Louis, Mo. "Somebody has to do it, and I was probablygoing to get it anyway," Sarakas said.

By Steve Sternberg, USA TODAYNicholas Sarakas says his mother urged him not to take part inpandemic vaccine trials. "She was worried about me. She didn't wantthem guinea-pigging me," he says. "She made me promise never to be inanother clinical trial."

Sarakas, 25, decided to volunteer anyway. A college student withouthealth insurance at the University of Missouri in St. Louis, hereasoned that he'd rather take his chances with the vaccine, and itsrisks, than pandemic flu.

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"There are people my age that are dying from this," he says.

Early Monday, Sarakas rolled up his sleeves for an injection in eacharm, becoming one of dozens of adults enrolling in an unprecedentedflurry of fast-track flu vaccine trials that will grow to include11,131 adults and 5,740 children, with more trials planned.

The vaccine is designed to blunt the effect of a virus that, startingthis fall, could infect 100 million people in the USA and cause 30,000to 90,000 deaths based on scenarios drawn from past pandemics, saysArnold Monto of the University of Michigan, an adviser to the Centersfor Disease Control and Prevention and the World Health Organization.About 36,000 people in the USA die each year of flu.

The virus, a new type of H1N1 strain also known as swine flu, has beenlinked to 6,506 hospitalizations and 436 deaths in the USA — up from353 a week ago — since it emerged in Mexico in April.

Too many volunteers to count

The U.S. government has ordered roughly 195 million doses of pandemicflu vaccine, in addition to the 120 million doses of seasonal fluvaccine expected to be available by the end of September.

"Vaccine is a huge component of the public health response toinfluenza," says Anthony Fauci, director of the National Institute ofAllergy and Infectious Diseases, which is sponsoring the trial thatenrolled Sarakas at Saint Louis University and four other trials ateight federally funded vaccine research centers across the country.

The flurry of swine flu vaccine trials, some sponsored by the U.S.government and others by five vaccine manufacturers, began late lastweek. Now people are clamoring to take part.

"We've had over 1,000 people call wanting to participate," says SharonFrey, lead investigator of the St. Louis study. "We've stoppedcounting."

Frey says she expects to meet her quota of 200 volunteers by nextweek, thanks to widespread publicity.

Side effects, dosages unknown

"I feel really lucky that I get to participate," says Karla Payne, 54,of Westchester, Ohio, who got her shots Monday in a study atCincinnati Children's Hospital Medical Center. "I used to work in thepublic schools. So many students didn't have money for health care.When I saw in the paper that they would start using schools tovaccinate kids, I thought, gosh, this would be a good thing to do,because they need to get vaccine out there."

The studies are necessary because so little is known about thepandemic vaccine, though many researchers believe it is likely to actmuch like seasonal vaccines, says Bruce Gellin, director of theDepartment of Health and Human Services National Vaccine ProgramOffice.

Flu vaccines historically have few side effects beyond redness andsoreness at the infection site. Studies of several thousand volunteersaren't big enough to detect more subtle side effects such as Guillain-Barré syndrome, a rare nerve ailment that crops up in one of everymillion flu vaccine recipients. Federal health agencies have ramped upsurveillance efforts to detect any severe side effects that mightoccur.

There are other uncertainties as well. For instance, vaccine makersdon't know how big a dose to give, how many doses will be needed perperson for protection and whether it will be necessary to add animmune-booster called an adjuvant.

Each one of those factors may affect how many people can bevaccinated. For instance, if the usual 15-microgram dose has to bedoubled, the number of people who could be vaccinated would fall to 98million. If two shots are required at double the dose, the number ofpeople who could be vaccinated would drop further, to 50 million.

Andrin Oswald, CEO of Novartis vaccines and diagnostics, says vaccinemakers also have found that the seed virus needed to make H1N1 vaccineproduces just half the yield of seasonal vaccine viruses. The lowyield may slow vaccine production so much that pandemic vaccine may bein short supply during the fall flu surge, he says.

"What we normally say in our orders to the government is that if theyield is 100%, we could deliver 10 million doses by December. If it'sonly 50%, it would take until March," Oswald says, adding thatmanufacturers now have a new seed strain that may boost yields.

"Timing is everything," Monto says. "We believe the second wave of fluwill come in the fall. If vaccine doesn't arrive until November-December, it won't do as much good."

By the numbers:

The U.S. government and five companies on Monday began injectingvolunteers to test a new vaccine to guard against the H1N1 flu strain.If effective, the vaccine will begin to be available to the generalpublic in mid October.